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Annexon Biosciences

Senior Director, Clinical Development (San Francisco)

Annexon Biosciences, San Francisco

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Company :

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body brain and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barr syndrome Huntingtons disease and geographic atrophy we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon youll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline check out our site Annexon Biosciences & Annexon Pipeline . We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane CA.

Were seeking exceptional talent from all backgrounds to fuel our growth. At Annexon were building a diverse equitable and inclusive workplace. We value unique perspectives and unconventional paths. If youre the best candidate for the job even if you dont perfectly fit the traditional mold we encourage you to more about our commitment to diversity equity inclusion and our company culture !

Position :

The Sr. Director of Clinical Development will serve as a key leader in driving the clinical strategy and execution of one or more development programs. This role will be responsible for the end-to-end design and execution of clinical programs from Phase I through Phase III ensuring scientific integrity regulatory compliance and alignment with corporate objectives . The Sr. Director will collaborate with cross-functional teams lead regulatory submissions and establish critical partnerships with key opinion leaders and external stakeholders to advance clinical initiatives. The ideal candidate will bring a strategic vision proven expertise in clinical trial design and execution and the ability to manage complex programs in a fast-paced environment. This individual will play a crucial role in translating innovative therapeutic concepts into real-world treatments shaping the companys success in the rapidly evolving field of neurology.

Responsibilities include :

  • Lead the strategic direction and execution of clinical development programs from early-phase through late-stage clinical trials ensuring they are scientifically robust and meet regulatory requirement.
  • Collaborate cross-functionally with teams in clinical operations regulatory affairs medical affairs pharmacovigilance and biostatistics to ensure the successful execution of clinical development plans.
  • Drive the preparation submission and management of regulatory filings including clinical trial applications investigator brochures and study protocols ensuring alignment with global regulatory guidelines (FDA EMA).
  • Analyze interpret and communicate clinical trial data to inform key decisions providing clear recommendations to guide clinical development strategy.
  • Establish and maintain strategic relationships with key opinion leaders (KOLs) clinical investigators and external stakeholders to advance clinical initiatives.
  • Manage clinical trial budgets timelines and resources ensuring the delivery of high-quality results aligned with corporate objectives.
  • Regularly present clinical progress data outcomes and strategic recommendations to executive leadership stakeholders and external partners.
  • Stay at the forefront of industry trends scientific advancements and regulatory developments to ensure the company remains competitive in the clinical development strategies.
  • Identify potential risks in clinical development timelines budgets or regulatory pathways and develop contingency plans to mitigate them.

Education Experience and Skills :

Required :

  • MD or PhD in Neurology Neuroscience or a related field.
  • Over 10 years of experience in clinical development with a focus on CNS-related indications.
  • Proven leadership in designing managing and executing clinical trials from early phase through late-stage development.
  • Demonstrated experience in leading clinical development teams at a senior or executive level ideally within a high-growth biotech or pharmaceutical environment.
  • In-depth knowledge of global regulatory requirements and guidelines (e.g. FDA EMA) and clinical development processes including Experience in HA meetings writing briefing books attending / supporting meetings .
  • Exceptional leadership strategic thinking and communication skills with a proven ability to influence across functions and levels.
  • Ability to work effectively in a fast-paced dynamic environment and manage multiple priorities.
  • Strong analytical and problem-solving skills with a data driven approach to decision making.
  • Demonstrated success in building collaborations with cross-functional teams and external partners in a dynamic fast paced environment.

    • Preferred :

  • Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting.
  • Familiarity with emerging trends in neurology including cutting-edge therapeutic modalities.

    • Salary Range : $336000 - $374000

    Location : Annexon Biosciences is located in Brisbane California and preference is given to candidates in the San Francisco Bay Area.

    Benefits :

  • A stimulating and rewarding workplace includes flexible work schedules remote opportunities and the ability to achieve a work-life balance.
  • Shuttle service from BART CalTrain and the Ferry.
  • Annexon offers a competitive base salary and equity participation employee stock purchase plan as well as a comprehensive health benefit package that includes medical dental vision 401(k) flexible spending plans and other benefits.

    • Annexon Biosciences is an Equal Opportunity Employer and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths views and experiences. We believe that our differences enable us to be a better team one that makes better decisions drives innovation and delivers better business results. Creativity and innovation flourish in an environment of openness inclusion and mutual respect.

    Required Experience :

    Exec

    Key Skills

    Fundraising,Management Experience,Biotechnology,Clinical Development,Clinical Trials,Research & Development,Training & Development,Grant Writing,Economic Development,Leadership Experience,Public Speaking,Product Development

    Employment Type : Full Time

    Experience : years

    Vacancy : 1

    Monthly Salary Salary : 336000 - 374000

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